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Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 13 Drugs Sold in Canada % All drugs sold in Canada must be approved by Health Canada. These include but are not limited to the following: drugs imported from other countries; drugs manufactured in Canada; drugs for export where the exporting company needs a Canadian approval in order to enter into another country.

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Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 21 Priority Review %... for a drug submission for a serious, life threatening or severely debilitating disease or condition for which there is substantial clinical evidence that the drug provides: % effective treatment/prevention/diagnosis of a disease or condition for which no drug is presently marketed in Canada… pdf

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Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 26 Drug Identification Numbers (DINs) and Notices of Compliance (NOC) DINS are issued to all drugs approved for marketing in Canada. (8 digit number generated by DPD) Must appear on the label Notification of first sale NOC are issued to all new drugs that are approved.

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Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 29 Why are Some Drugs not Approved? % All drugs must be reviewed to ensure that they meet the requirements of the Food and Drugs Act and Regulations % Drug must have sufficient evidence to support the safety, efficacy or quality claims, to be approved % Drug companies may submit further info. to ensure that the safety, efficacy, and quality standards are met (e.g. may require further research in animals and/or humans) % HPFB decision not to approve a drug may be appealed by applicant

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Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 39 International Harmonization % HPFB has been very active in helping develop and implement international standards for the registration of new drugs. HPFB has contributed significantly to the development of over 45 harmonized technical guidelines. Canada is the only observer country to the International Conference on Harmonization (ICH) and is committed to implementing finalized ICH guidelines and standards including the Common Technical Document (CTD).

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Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 44 The TPD Journey from where we are….to where we need to be Some of the timeMeet Performance Target Not alwaysPredictable Not necessarilyConsistent Resource poorSustainable Not veryTransparent Current State Desired State